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510(k) Data Aggregation
K Number
K163432Device Name
Stellar LEAP
Manufacturer
Date Cleared
2017-06-27
(202 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
PDG Product Design Group, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Stellar LEAP Manual Tilt Wheelchair is intended to provide mobility to persons restricted to a seated position.
Device Description
The Stellar LEAP manual tilt wheelchair is an indoor / outdoor, manually operated, Tilt-in-Space wheelchair. Its intended function and use is to provide mobility to persons ages 16 and up (adolescents and adults). The Stellar LEAP manual tilt wheelchair consists of metal frame architecture with a backrest, seat, and rear wheels, which allow for occupant or attendant propelling of the device. Smaller caster wheels are also mounted on the front of the frame to facilitate steering and turning. The Stellar LEAP consists of three (3) metal frame subassemblies: a lower frame, upper seat frame, and sub-frame assembly. The manual Tilt-in-Space operation is achieved using a gas strut mechanism connected between the upper seat frame and sub-frame. The Stellar LEAP Manual Tilt Wheelchair is available in a standard configuration, which allows 20° Tilt-in-Space (posterior) tilt, with a maximum weight capacity of 250 lbs.
PDG offers optional features / options to be added to the Stellar LEAP wheelchair, including the two below features:
- Stellar LEAP Anterior Tilt Feature (0° 30°): Functional reach extension & transfer . assist
- Stellar LEAP Dynamic Recline Backrest Tilt Feature: 30° range of dynamic recline for the backrest combined with the anterior tilt
Other available options / accessories to complete the Stellar LEAP configuration include: seat width / depth / height, armrests, casters, frog leg suspension forks, rear wheel / tire, hand rim, wheel locks, anti-tippers, back post style, back options, back upholstery, headrest, tilt control, recline control, front rigging, foot plates, footrest / leg rest accessories, position straps, IV pole, 02 holder.
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K Number
K140023Device Name
ELEVATION
Manufacturer
Date Cleared
2014-10-16
(283 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
PDG PRODUCT DESIGN GROUP, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Elevation Manual Wheelchair is intended to provide mobility to persons limited to a seated position.
Device Description
The PDG Product Design Group, Inc. Elevation Manual Wheelchair (Elevation) is a manually operated, user propelled, manual, mechanical wheelchair. Its intended function and use is to provide mobility to persons ages 12 and up (adolescents and adults) limited to a seated position. It is an ultra-light, rigid (non-folding frame) type wheelchair.
The device consists primarily of a lower frame assembly, a seat sling, a back rest and back upholstery, large rear wheels with hand rims for self-propelling the chair and front swivel type pivoting casters for turning.
The Elevation also has seat height and back rest recline angle adjustment capability that allow the user to self-adjust either the seat to floor height or the back rest recline angle while seated in the wheelchair. The Elevation is capable of up to 5 inches of rear to front seat height difference.
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K Number
K063736Device Name
FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50
Manufacturer
Date Cleared
2007-01-17
(30 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
PDG PRODUCT DESIGN GROUP, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To provide mobility to persons limited to a seated position.
Device Description
The PDG Models Fuze T20 and T50 wheelchairs are manually operated, self propelled mechanical wheelchairs. Their intended function and use is to provide mobility to persons that may be limited to a seated position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility.
Both wheelchairs include a tilt mechanism which allows the upper frame of the wheelchair to be tilted. This feature is used to provide pressure relief as well as comfort to those users who may be confined to the wheelchair for extended periods of time. The tilt mechanism can also serve as an attendant aid in those situations where a patient needs to be tilted for attendant access.
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K Number
K061475Device Name
ASTROTILT MANUAL WHEELCHAIR
Manufacturer
Date Cleared
2006-06-14
(15 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
PDG PRODUCT DESIGN GROUP, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To provide mobility to individuals limited to a sitting position.
Device Description
Not Found
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K Number
K990557Device Name
THE STELLAR TILT, MANUALLY OPERATED WHEELCHAIR
Manufacturer
Date Cleared
1999-03-22
(28 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
PDG PRODUCT DESIGN GROUP, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the device is in providing mobility to persons restricted to a sitting position.
Device Description
The Stellar Tilt, Manually Operated Wheelchair
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K Number
K971389Device Name
ECLIPSE 400 MANUALLY OPERATED WHEELCAIR
Manufacturer
Date Cleared
1997-05-09
(25 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
PDG PRODUCT DESIGN GROUP, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K970311Device Name
BENTLEY MANUALLY OPERATED WHEELCHAIR
Manufacturer
Date Cleared
1997-02-14
(18 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
PDG PRODUCT DESIGN GROUP, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K961743Device Name
ECLIPSE 600 MANUALLY OPERATED WHEELCHAIR
Manufacturer
Date Cleared
1996-05-29
(26 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
PDG PRODUCT DESIGN GROUP, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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